{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Multicomponent digital weight management × At least 5% weight loss",
  "language": "en",
  "translation_date": "2026-10-14",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "Existing content review remains incomplete.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Selected 5% claim and original grade",
      "needed": "Distinction between the original responder question/grade and the parent mean-weight verdict",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between the original responder question/grade and the parent mean-weight verdict to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for distinction between the original responder question/grade and the parent mean-weight verdict must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up comparison specifying the responder question and hierarchy; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Definition of the 5% threshold",
      "needed": "Threshold, reference weight, calculation/time point and responder-adjudication rules",
      "role": "Required",
      "role_reason": "An applied item distinguishing threshold, reference weight, calculation/time point and responder-adjudication rules to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for threshold, reference weight, calculation/time point and responder-adjudication rules must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up study specifying thresholds, measurement and time points; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "40% versus 17% and P value",
      "needed": "Distinction between original proportions, group correspondence, P value and new arithmetic",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between original proportions, group correspondence, P value and new arithmetic to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for distinction between original proportions, group correspondence, P value and new arithmetic must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; CHAMGAP adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are designed by CHAMGAP; M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study reporting proportions together with uncertainty and denominators; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Responder denominators and event counts",
      "needed": "Randomized, observed and model denominators and actual responder counts",
      "role": "Required",
      "role_reason": "An applied item distinguishing randomized, observed and model denominators and actual responder counts to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for randomized, observed and model denominators and actual responder counts must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study reporting enrolled, observed and estimated denominators separately; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Proportion effects, CIs and precision",
      "needed": "Original proportions, prespecified effect measures, CIs and clinical importance",
      "role": "Required",
      "role_reason": "An applied item distinguishing original proportions, prespecified effect measures, CIs and clinical importance to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for original proportions, prespecified effect measures, CIs and clinical importance must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 Table 8.2.a, M04 §4.6.3; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up study disclosing effect measures and uncertainty; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Mean change is a different endpoint",
      "needed": "Distinction between continuous means and threshold-attainment distributions/proportions",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between continuous means and threshold-attainment distributions/proportions to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for distinction between continuous means and threshold-attainment distributions/proportions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up trial distinguishing mean and responder endpoints; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Secondary endpoint and prespecified hierarchy",
      "needed": "Distinction between the primary mean endpoint and secondary 5% responder result",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between the primary mean endpoint and secondary 5% responder result to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for distinction between the primary mean endpoint and secondary 5% responder result must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study distinguishing the primary endpoint from prespecified responder analyses; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Measured weight and responder-adjudication values",
      "needed": "Correspondence between visit weight, self-monitoring/self-report and proportion calculations",
      "role": "Required",
      "role_reason": "An applied item distinguishing correspondence between visit weight, self-monitoring/self-report and proportion calculations to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for correspondence between visit weight, self-monitoring/self-report and proportion calculations must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study linking measured/remote measurements with responder calculations; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Population, comorbidities and recruitment",
      "needed": "Obese population aged 21–65 with baseline conditions and applicability scope",
      "role": "Required",
      "role_reason": "An applied item distinguishing obese population aged 21–65 with baseline conditions and applicability scope to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for obese population aged 21–65 with baseline conditions and applicability scope must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up study specifying applicability by population; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Attribution within multicomponent Track",
      "needed": "The full bundle versus individual effects of app/counseling and other components",
      "role": "Required",
      "role_reason": "An applied item distinguishing the full bundle versus individual effects of app/counseling and other components to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for the full bundle versus individual effects of app/counseling and other components must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up comparison distinguishing bundle and component attribution; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Component plans and actual use",
      "needed": "Delivery/exposure for app feedback, daily scale use, 18 calls and clinical integration",
      "role": "Required",
      "role_reason": "An applied item distinguishing delivery/exposure for app feedback, daily scale use, 18 calls and clinical integration to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for delivery/exposure for app feedback, daily scale use, 18 calls and clinical integration must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up study distinguishing plans from actual exposure and response; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Usual-care control",
      "needed": "Actual control management, contact and additional-exposure conditions",
      "role": "Required",
      "role_reason": "An applied item distinguishing actual control management, contact and additional-exposure conditions to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for actual control management, contact and additional-exposure conditions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up trial disclosing actual comparison conditions; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "12-month assessment, maintenance and regain",
      "needed": "Distinction between the selected responder time point and persistence during or beyond follow-up",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between the selected responder time point and persistence during or beyond follow-up to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for distinction between the selected responder time point and persistence during or beyond follow-up must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study reporting threshold attainment separately from maintenance/regain; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Randomization and allocation concealment",
      "needed": "Historical allocation-procedure narrative and current access to originals",
      "role": "Required",
      "role_reason": "An applied item distinguishing historical allocation-procedure narrative and current access to originals to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for historical allocation-procedure narrative and current access to originals must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Assessor masking and participant expectations",
      "needed": "Scope of masking for outcome assessors and participants",
      "role": "Required",
      "role_reason": "An applied item distinguishing scope of masking for outcome assessors and participants to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for scope of masking for outcome assessors and participants must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study distinguishing masking from participant behavior/expectation scope; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "ITT and responder-analysis population",
      "needed": "Overall ITT principle versus actual denominators/populations for secondary proportions",
      "role": "Required",
      "role_reason": "An applied item distinguishing overall ITT principle versus actual denominators/populations for secondary proportions to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for overall ITT principle versus actual denominators/populations for secondary proportions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study separately disclosing analysis populations for continuous and responder outcomes; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Maximum-likelihood missing data and proportion handling",
      "needed": "Distinction between primary-analysis missing-data estimation and handling of unobserved responders",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between primary-analysis missing-data estimation and handling of unobserved responders to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for distinction between primary-analysis missing-data estimation and handling of unobserved responders must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study reporting endpoint-specific missing-data handling and effects separately; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Attrition, non-observation and missed visits",
      "needed": "Group-specific timing, causes and response effects of attrition/missingness",
      "role": "Required",
      "role_reason": "An applied item distinguishing group-specific timing, causes and response effects of attrition/missingness to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for group-specific timing, causes and response effects of attrition/missingness must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up study disclosing effects of non-observation and response adjudication; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Proportion tests, within/between groups and adjustment",
      "needed": "Proportion contrasts and original model, test and adjustment conditions",
      "role": "Required",
      "role_reason": "An applied item distinguishing proportion contrasts and original model, test and adjustment conditions to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for proportion contrasts and original model, test and adjustment conditions must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study clearly reporting proportion estimands and tests; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Registration and advance responder plans",
      "needed": "NCT identifier and scope of advance plans for primary/secondary proportion endpoints",
      "role": "Required",
      "role_reason": "An applied item distinguishing nCT identifier and scope of advance plans for primary/secondary proportion endpoints to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for nCT identifier and scope of advance plans for primary/secondary proportion endpoints must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study openly linking registration with actual secondary analyses; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Multiple outcomes, hierarchy and time points",
      "needed": "Multiplicity in testing responders and other time points/endpoints",
      "role": "Required",
      "role_reason": "An applied item distinguishing multiplicity in testing responders and other time points/endpoints to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for multiplicity in testing responders and other time points/endpoints must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; own application; M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is independently applied; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study separating primary endpoints from secondary proportions and other outcomes; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Thresholds, importance and disease events",
      "needed": "Distinction between 5% response, advance success/importance criteria and clinical outcomes",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between 5% response, advance success/importance criteria and clinical outcomes to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for distinction between 5% response, advance success/importance criteria and clinical outcomes must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; custom application; M03 §3.2.4; custom extension boundary; M08 Table 8.2.a, M04 §4.6.3; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up study distinguishing responders from clinical outcomes; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Concurrent management, medication and lifestyle",
      "needed": "Concurrent conditions/medication, lifestyle/clinical exposure and responder outcomes",
      "role": "Required",
      "role_reason": "An applied item distinguishing concurrent conditions/medication, lifestyle/clinical exposure and responder outcomes to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for concurrent conditions/medication, lifestyle/clinical exposure and responder outcomes must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up study distinguishing concurrent management from responder outcomes; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "NIH public support",
      "needed": "Distinction between funder/grant, support roles and independence",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between funder/grant, support roles and independence to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for distinction between funder/grant, support roles and independence must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up trial disclosing support/research roles; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Non-reporting of support in the pivotal paper",
      "needed": "Category-specific scope of commercial, in-kind, outsourced-analysis/writing and publication support",
      "role": "Required",
      "role_reason": "An applied item distinguishing category-specific scope of commercial, in-kind, outsourced-analysis/writing and publication support to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for category-specific scope of commercial, in-kind, outsourced-analysis/writing and publication support must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study disclosing support categories distinctly; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Later author relationships and disclosure timing",
      "needed": "Distinction between later WW/Coeus disclosures and original-trial timing/roles",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between later WW/Coeus disclosures and original-trial timing/roles to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for distinction between later WW/Coeus disclosures and original-trial timing/roles must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "Chamgap’s custom independence/attribution conditions. The official methodology sections used in this pilot do not guarantee all these detailed items; M04 §4.5, §4.6.3; current conversion limits reflect review scope and custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study distinguishing relationship/support attribution by period; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "References to null results from other programs",
      "needed": "Directness of Track’s bundle versus app-only/low-intensity programs",
      "role": "Required",
      "role_reason": "An applied item distinguishing directness of Track’s bundle versus app-only/low-intensity programs to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for directness of Track’s bundle versus app-only/low-intensity programs must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed direct follow-up comparison matching composition and intensity; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Same report, sibling sheets and independence",
      "needed": "Mean/responder, report/registration and group/time-point relationships",
      "role": "Required",
      "role_reason": "An applied item distinguishing mean/responder, report/registration and group/time-point relationships to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for mean/responder, report/registration and group/time-point relationships must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed independent follow-up comparison specifying the same secondary threshold; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Persistence and applicability to other compositions/populations",
      "needed": "Distinction between Track responder results and long-term/stand-alone-app/other-population effects",
      "role": "Required",
      "role_reason": "An applied item distinguishing distinction between Track responder results and long-term/stand-alone-app/other-population effects to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for distinction between Track responder results and long-term/stand-alone-app/other-population effects must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are custom design; M03 §3.2.4; custom extension boundary; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study distinguishing threshold attainment from persistence/applicability; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N30",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Unknown safety and collection gaps",
      "needed": "Prespecification, collection/denominators and follow-up for adverse events",
      "role": "Supplementary",
      "role_reason": "An applied item distinguishing prespecification, collection/denominators and follow-up for adverse events to connect the selected question’s needed materials with current materials.",
      "application_exception": "Supplements safety-data gaps for the selected subclaim. Mean weight, 5% responder results and parent caution wording are not used to judge safety or generate harm incidence or new use instructions.",
      "criterion": "Corresponding original materials and analysis scope for prespecification, collection/denominators and follow-up for adverse events must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed follow-up study specifying harm collection and follow-up; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Parent/subclaim, Korean/English, corrections and history",
      "needed": "Separate preservation of original values/axes, reference dates and verification narratives",
      "role": "Required",
      "role_reason": "An applied item distinguishing separate preservation of original values/axes, reference dates and verification narratives to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for separate preservation of original values/axes, reference dates and verification narratives must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed research distinguishing original values/history from new-update scope; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Summary reading, external links and updates",
      "needed": "Actually read scope and access status of external materials",
      "role": "Required",
      "role_reason": "An applied item distinguishing actually read scope and access status of external materials to connect the selected question’s needed materials with current materials.",
      "application_exception": "Limited to the preserved summary’s selected strategy/population/endpoint/period. It does not replace numbers for other strategies/trials/endpoints or unread external materials.",
      "criterion": "Corresponding original materials and analysis scope for actually read scope and access status of external materials must be available and unverified matters distinguishable. Preserved wording is linked here; existing content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A proposed study updating acquisition, timing and scope of materials separately; no new investigation, calculation or trial was performed."
    }
  ]
}